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    Associate Manager, Pss

    Fortrea
    2+ years
    Not Disclosed
    Bangalore
    10 Nov. 8, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Patient Safety Solutions (PSS) Manager - Fortrea

    Location: Bangalore, India
    Company: Fortrea

    About Fortrea
    Fortrea is a global leader in clinical research with a passion for scientific rigor and decades of experience in clinical development. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in 90+ countries, Fortrea is transforming the future of drug and device development to meet the needs of both our partners and patients worldwide.

    Job Overview

    Fortrea is seeking an experienced Patient Safety Solutions (PSS) Manager to join our team in Bangalore. The PSS Manager will line manage PSS staff, oversee performance reviews, and assist in resource allocation for client projects. This role is responsible for ensuring high-quality service to clients, managing the processes for adverse events (AEs) and expedited safety reports (ESRs), and maintaining compliance with regulatory requirements.

    Key Responsibilities

    • Line Management: Oversee a team of PSS staff, conducting performance reviews and addressing HR issues. Mentor and provide career guidance to junior staff.
    • PSS Operations Management: Ensure the timely and accurate processing of adverse event reports and expedited safety reports, maintaining compliance with client and regulatory timelines.
    • Team Coordination: Lead team meetings and coordinate with cross-functional teams for resource allocation and project assignments.
    • Safety Report Management: Supervise the entry and review of safety data, including MedDRA coding, patient narratives, and expectedness analysis. Ensure proper escalation and reporting to regulatory bodies as needed.
    • Training & Development: Provide training to new employees and ensure ongoing staff development in pharmacovigilance and regulatory reporting.
    • Client & Regulatory Compliance: Ensure safety reporting adheres to international regulations, SOPs, and client-specific requirements. Prepare reports for clients, regulatory authorities, and ethics committees.
    • Project Support: Manage expedited safety report (ESR) submissions, update tracking systems, and assist with reconciliation efforts across safety databases.
    • Continuous Improvement: Identify opportunities for process improvements and lead initiatives to enhance PSS team efficiency and effectiveness.
    • Team Leadership: Assist with staff recruitment and retention, fostering a collaborative, motivated, and high-performing team environment.

    Qualifications

    Required

    • Experience: A minimum of 7+ years in pharmacovigilance, including 2 years in a leadership role.
    • Knowledge: Expertise in adverse event reporting, MedDRA coding, and safety database management. Strong understanding of Good Clinical Practice (GCP) and regulatory requirements for pharmacovigilance.
    • Skills: Excellent leadership, communication, and interpersonal skills. Ability to manage multiple priorities and provide strategic guidance to staff.
    • Regulatory Understanding: Knowledge of global safety reporting regulations, including ICH, FDA, EMA, and local regulatory guidelines.
    • Technical Proficiency: Strong knowledge of safety tracking systems and MS Office.
    • Education: Degree in life sciences, pharmacy, biotechnology, or a related field.

    Preferred

    • EudraVigilance Certification or other relevant pharmacovigilance certifications.
    • Experience in Medical Device Reporting and aggregate reporting.
    • Strong problem-solving and strategic thinking capabilities.

    Physical Demands / Work Environment

    • Travel: Available for 10% travel, including overnight stays, as required for project needs.
    • Environment: Office-based or remote depending on location and project requirements.

    Why Join Fortrea?

    At Fortrea, we are passionate about overcoming the barriers in clinical trials and making a meaningful impact on global healthcare. We foster a collaborative work environment where personal growth is nurtured, and you have the opportunity to contribute to groundbreaking solutions that transform the drug development process. If you are a motivated and innovative problem-solver with a passion for patient safety and regulatory compliance, we encourage you to apply.

    To learn more about Fortrea and explore exciting career opportunities, visit www.fortrea.com.

    Equal Opportunity Employer

    Fortrea is committed to diversity and inclusion and does not discriminate against individuals based on race, religion, color, gender identity, age, disability, or any other protected status. We value a workforce where all employees can thrive and contribute to our success. We encourage all qualified individuals to apply.

    Privacy Statement

    For more information about how Fortrea collects and stores your personal data, please see our Privacy Statement.

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